BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOLINQ INCORPORATED

    Reg #: 3025798257 · FEI: 3025798257 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    BIOLINQ INCORPORATED
    Registration Number
    3025798257
    FEI Number
    3025798257
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10260 Sorrento Valley Rd
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240080

    Owner / Operator

    Firm Name
    Biolinq Incorporated
    Operator Number
    10094164
    Address
    10260 Sorrento Valley Road
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    Products

    Device Name Product Code
    Glucose Range Monitoring System SFU
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Biolinq Shine Autonomous Time-in-Range Microsensor Biolinq Shine Sensor Cover

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device